Functional connectivity–guided transcranial magnetic stimulation for alcohol use disorder

Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

This study will test whether a single fMRI-guided session of transcranial magnetic stimulation (TMS) can reduce alcohol-cue brain reactivity and help people with moderate-to-severe alcohol use disorder stay abstinent.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 25 Years to 75 Years
• Sex: All
• Sponsor: VA Palo Alto Health Care System (fed)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06415721 on ClinicalTrials.gov

What this trial studies

Participants will undergo fMRI to identify each person's peak brain response to alcohol cues and then receive either active, personalized TMS delivered to that target or a sham procedure. The trial compares one session of fMRI-guided TMS against sham stimulation and monitors changes in brain cue-reactivity and drinking outcomes over follow-up. Eligible participants are adults with DSM-5 moderate-to-severe AUD who can attend in-person visits. The approach aims to use individualized neuroimaging targets to improve the precision and effectiveness of noninvasive neuromodulation for relapse prevention.

Who should consider this trial

Good fit: Adults aged 25–75 with a current DSM-5 diagnosis of moderate-to-severe alcohol use disorder who can attend scheduled in-person visits at the study site, read English, and maintain a stable medication regimen are ideal candidates.

Not a fit: People with contraindications to MRI or TMS (for example pacemakers, certain implants, pregnancy, claustrophobia), unstable medical or neurological conditions, or other factors preventing safe participation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this personalized, noninvasive approach could lower cue-driven brain reactivity and reduce relapse rates, offering a new treatment option for people with AUD.

How similar studies have performed: Retrospective analyses and early neuromodulation research suggest that targeting an individual's peak alcohol-cue response with TMS can improve abstinence rates, but fMRI-guided single-session protocols remain experimental and require prospective validation.

Eligibility criteria

Inclusion Criteria:

* Between age 25 and 75.
* Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
* Able to attend scheduled clinic visits
* Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
* If on a medication regimen, that regimen will be stable for the duration of the study;
* Fluency in English.

Exclusion Criteria:

* Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
* General medical condition, disease or neurological disorder that interferes with the assessments or participation.
* Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
* Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
* Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
* Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
* unstable chronic illness.
* Current or lifetime history of bipolar disorder or psychosis.
* Participation in another concurrent intervention based clinical trial.

Where this trial is running

Palo Alto, California

• VA Palo Alto Health Care System — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel McCalley, PhD — Palo Alto VA Health Care System
• Study coordinator: Daniel McCalley

Conditions: Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Drinking Behavior, Drinking Problem, Transcranial Magnetic Stimulation, Veterans, Neuroimaging